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NIST SP 951
Some manufacturers are reluctant to prepare written design reviews. They reason that such reviews could be used against them in a product liability lawsuit. Not recognizing or effectively dealing with a hazard, however, is not a winning argument. A more powerful defense is available when the manufacturer can show awareness of hazards, and can also show how risks to the user were minimized through the thoughtful application of design, guarding, and instructions. In all cases, the directive should be looked to for direction. For example, Annex I of the Machinery Directive contains specific detailed technical requirements that are to be followed in conducting a risk assessment. User's Manual
LanguageThe user's manual must be written in one official language of the European Union (English is one of the official languages) and/or in the language of the country where the product will be used. Because its proper use is critical to the safety of the user, a prudent manufacturer will make sure that a competent technical translator translates the user's manual. Applying drawings and pictograms is widely accepted in the European Union and is cost effective from a translation point of view. Declaration of ConformityAfter performing a critical design review, making changes to the product design that will minimize risks of harm, and compiling the Technical File, the manufacturer may affix the CE marking and prepare a Declaration of Conformity. New Approach Directives require the issuance of a Declaration of Conformity by the manufacturer or his Authorized Representative. A Declaration of Conformity is a document informing Surveillance Authorities that the product meets the essential requirements of the applicable directives, or that the product has been issued an EC type-examination certificate, and meets the essential requirements of the applicable directives. Return to the Table of Contents
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